ASPIRIN- aspirin tablet 
Advance Pharmaceutical Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ENTERIC COATED ASPIRIN 325mg

Active Ingredient

(in each tablet)

Aspirin 325 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves

Warnings

Reye’s Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

Other Information

Inactive Ingredients

croscarmellose sodium, D&C Yellow #10 (Al-Lake), FD&C yellow #6 (Al-Lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, PVP,  sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions or Comments

Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Safer for your stomach than pain or Buffered Aspirin

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC: 17714-011-01 – 100 Tablets

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AP;011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17714-011-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
2NDC:17714-011-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/08/1990
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-011)

Revised: 10/2017
Document Id: 5cc9070d-57cd-a48a-e053-2a91aa0a449e
Set id: 968afa79-eaae-4cd9-ba0d-3b5eaa466b58
Version: 3
Effective Time: 20171030
 
Advance Pharmaceutical Inc.